Ketamine interleaved with electroconvulsive therapy for depression, a pragmatic randomised controlled pilot trial (KITE-Dep)

Phase 1

• Conditions: Depression; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2018-003421-28-IE
• Lead Sponsor: St Patrick's Mental Health Services

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-28
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•=18 years old
•Able to provide informed consent
•Voluntary admission for treatment of an acute depressive episode
•Meet DSM-V criteria for a major depressive disorder (MDD) and bipolar affective disorder (current episode depression)
•Montgomery Asberg Depression Rating Scale 10 item version (MADRS) score of =20
•Referred for treatment with ECT
•Sufficiently physically healthy to receive ketamine/midazolam and ECT

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

•Inability to provide informed consent
•Current involuntary admission
•History of Axis 1 diagnosis other than major depression
•Medical condition rendering unfit for ketamine/midazolam or ECT
•Active suicidal intention
•Presence of major neurological or organic brain disorder
•Alcohol/substance dependence in previous six-months
•Pregnancy or inability to confirm use of adequate contraception during the trial
•Breastfeeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified